Key Issues: Pilliods v. Monsanto/Bayer Late March 2019 Trial

A late March start date is scheduled for a California state court trial of plaintiffs, Alva and Alberta Pilliod, against Monsanto/Bayer claiming 26–35 years of Roundup herbicide use on four properties caused each to incur different types of Non-Hodgkin’s Lymphoma (NHL). Case information regarding case is limited as court documents are inaccessible or heavily redacted, but an extract from a defense motion identifies a variety of potential risk factors for NHL cancers:

The Pilliods have different sub-types of NHL. Mr. Pilliod has diffuse large B-cell lymphoma (DLBCL), a subtype of NHL that accounts for thirty to thirty-five percent of all cases. Ex. 1, Nabhan Pilliod Dep. at 28:2–9. Mr. Pilliod was diagnosed in 2011 at the age of sixty-nine. Ex. 6, Nabhan Pilliod Rep. at 22. Mrs. Pilliod was diagnosed in 2015, shortly before her seventy-first birthday, with a different subtype of NHL known as primary central nervous system lymphoma (PCNSL), a rare subtype of DLBCL. Id. at 5; Ex. 1, Nabhan Pilliod Dep. at 112. The Pilliods have a multitude of risk factors associated with development of NHL. First, age is a significant risk factor for both Plaintiffs. Ex. 1, Nabhan Pilliod Dep. at 21:9–17. Second, both Plaintiffs have a history of xxxxxxxxxxxxxxxxxxx. Ex. 6, Nabhan Pilliod Rep. at 8, 14, 29. Third, both Plaintiffs have a personal history of xxxxxxxxxxxxxxxx . See Ex. 1, Nabhan Pilliod Dep. 45:5–46:22; Ex. 6, Nabhan Pilliod Rep. at 7; Ex. 3, Weisenburger Pilliod Dep. 193:14–21. Fourth, both Plaintiffs have a family history of xxxxxxxxxxxxxxxxxx. See Ex. 6, Nabhan Pilliod Rep. at 8; Ex. 3, Weisenburger Pilliod Dep. at 50:13–18; Ex. 1, Nabhan Pilliod Dep. 43:22–45:4. Fifth, the Pilliods have a history of xxxxxxxxxxxxxx, with Mrs. Pilliod . Ex. 6, Nabhan Pilliod Rep. at 8; Ex. 3, Weisenburger Pilliod Dep. at 203:2–23. Sixth, Mrs. Pilliod had xxxxxxxxxxxxxxxxxxxxxxxxxxx,” and Mr. Pilliod had xxxxxxxxxxxxxxxxxxxxxxxxxxx at 111:15–112:17; Ex. 1, Nabhan Pilliod Dep. at 61:2–8. Seventh, Mrs. Pilliod worked for years as a xxxxxxxxxxxxx, thereby having increased exposure to children and childhood viruses, which studies show carries a statistically significant increased risk of developing NHL. See Ex. 1, Nabhan Pilliod Dep. at 351:6–353:19. Eighth Mr. Pilliod has had xxxxxxxxxxxxxxxxxxx , which has been linked to NHL. Id. at 62:22–63:13; Ex. 3, Weisenburger Pilliod Dep. at 185:21–24.

Potential risk factors will be compared to studies such as Koff et al 2015 to identify the strength of biological and epidemiological links to NHL cancer sub-types. For example, these tables show strength of association (>2.0 odds ratio indicates “more than likely”) by exposure category to NHL sub-types, including DLBCL cancer:

The Villiods’ trial will be held in California state court in Oakland and will not be bifurcated into causation and liability phases as the Hardeman federal court trial. Many aspects will be similar to Johnson trial which was tried in San Francisco state court and a large percentage of trial time will be devoted to interpretation and context of Monsanto historical documents as well as alleged effects on scientific review publications. Bayer/Monsanto recently issued following commentary in response to questions regarding Health Canada’s second review of glyphosate, including selected Monsanto historical documents:

In addition, testimony may denote differences for overall conclusions and detailed portions of analysis between the International Agency for Research on Cancer (IARC) and every other major regulatory/scientific agency world-wide, including U.S. Environmental Protection Agency (EPA), European Food Safety Authority (EFSA) Heath Canada and others. At base, IARC performs a hazard analysis (there are sharks in ocean) versus the risk analysis (sharks risks to humans) performed by EPA and other regulatory agencies. Notably, key epidemiological studies (American Health Study and North American Pooled Project) published updates subsequent to the IARC analysis in early 2015.

During the trial there will be estimates of exposure to Roundup spraying activity, but more than likely will approximate the unchallenged and extraordinarily excessive spraying activities identified in the previous Roundup trials of Johnson and Hardeman. A plaintiff’s motion claims the Pilliods sprayed for 31–45 days per year for 35 years. There are obvious practical difficulties incurred by the defense when challenging household purchases and extent of spraying activities for previous decades. This anecdotal evidence will help plaintiffs plant the image of high exposure levels for jurors and incur minimal risk of the defense challenging for credibility or reasonableness of spraying activities.

General causation (NHL cancer association with Roundup) experts may be presented by both sides for testimony regarding animal and cellular studies, but these categories should have little overall significance because of difficulty of relating to human causation. Plaintiff’s experts will use a scatter gun approach for identification of specific animal or cellular studies positive for their case without a defined and predetermined methodology; i.e., an overall weight of evidence approach including factors such as predetermined weights for different types of tests, biological relevance, relevance for humans, etc.. Also unknown is whether Monsanto/Bayer will counter plaintiff experts with defense experts (Johnson trial) or vigorous cross-examination (Hardeman trial). Plaintiff expert conclusions for animal and mechanistic studies will always be irreconcilable with defense and regulatory/scientific conclusions because of methodological differences even with agreement on specific studies because the overall weight of evidence as well as the weighting and relevance of component study types. Obviously, a jury trial is not the best mechanism for resolving these differences. There are three studies which will be heavily discussed; the coca eradication studies of Colombians and Ecuadorians exposed to 10x-20x the recommended spraying dosage for glyphosate based formulations. Plaintiff’s experts will place a high value these studies while the defense will evaluate these studies similarly to the combined EPA and National Toxicology Program analysis and all other world-wide regulators which determined the studies used laboratory tests for identifying transitory changes which could have occurred because of acute exposures and/or unreliable protocols and are therefore, at best, inconclusive.

The major emphasis of general causation testimony will be epidemiological studies because these studies track the incidence of NHL cancers for subjects, normally farmers who are exposed to Roundup or other glyphosate based formulations. Plaintiff specific causation medical experts will use these results to extrapolate to Pilliods NHL cancers and likely expert testimony will include several studies. Plaintiff will point out statistically significant Eriksson study and defense will point out notable errors and lack of statistically significant result because there was no adjustment for confounding pesticides. Plaintiff will identify statistically significant result for McDuffie and defense will delineate multiple forms of bias and lack of significant result because there was no adjustment for confounding pesticides. Plaintiff will indicate De Roos 2003 has a statistically significant association to NHL cancers and defense will note a large percent of interviewed study subjects were proxies for actual subjects and the statistically significant result is invalid because of “data sparcity”; i.e., the logistic regression technique used to predict association of NHL cancer had only 36 exposed cases of NHL and 47 pesticide variables when at least five (better 10) exposed cases are needed for each of the 47 variables for a valid result. Plaintiff’s may discuss an updated study (aka Pahwa 2015) of the North American Pooled Project (NAPP), but the defense will definitely note NAPP pools McDuffie and De Roos study results and the lack of a significant statistical association for any of various metrics. Last, but not least because of its enormous relative size, is the Agricultural Health Study which plaintiff will roundly criticize and defense will point out all of the comparative and sensitivity sub-studies which address plaintiff’s criticisms and also note none of the many statistically significant results show a NHL and Roundup association. Plaintiffs may also choose to testify regarding the Zhang 2019 Meta-Analysis for identifying a 41% increased relative probability for NHL cancer associated with intense Roundup usage and defense will respond, as in Hardeman trial, with a thorough demolition of the meta-analysis. Interestingly, if more realistic choices are made for studies to be included as well as latency lag time, the same meta-analysis would reflect no association between NHL cancers and Roundup:

Plaintiff medical experts will attempt to infer from epidemiological studies and assign NHL cancer responsibility to Roundup in spite of other causative factors and defense’s medical experts will do the opposite with results presented to jury perhaps limited by Judge’s rulings for allowable inferences.

Predictably, closing arguments for the Pilliods will mirror the Johnson trial closings because of the intermixing of causation and document interpretation allegations. Again, as with Johnson case, the jury verdict will largely depend on degree of influence for alleged corporate wrongdoing, judicial rulings with respect to epidemiological inferences and the strength of other, as yet defined, causal medical factors.

Predictably, jurors will base verdict on a confusing and complicated mixture of scientific conclusions dosed with junk science as well as interpretations of historical corporate documents and the verdict will pass to the reasoned post-trial and appeals process for resolution.